Dimension Ferritin (FERR) Flex reagent cartridge recallZ-2229-2019 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 15, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Negative Bias with Lot EA9227.
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens sent an Urgent Field Safety Notice letter dated July 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Review the letter with their Medical Director 2. Discontinue use and discard the kit. 3. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. send a scanned copy of the completed form via email to or fax this completed form to the Customer Care Center at 312-275-7795. 4. If you have received any complaints of illness or adverse events associated with the product listed in the letter, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative. 5. Retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Recall details
- Recall number
- Z-2229-2019
- Status
- Terminated
- Initiated by the company
- Jul 15, 2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 815 kits
- Product code
- JMG
- FDA submissions
- K963498
- Distribution
- Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS MT NC NE NH NJ NY OK OR PR SD TN TX VA VT WA WI
Product description
Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
Code information (models, lots, serial numbers)
Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dimension® Flex® reagent cartridge FERR 10444946Siemens Healthcare Diagnostics Inc. · Radioimmunoassay (two-site solid phase), ferritin1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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